Biosimilars battle in clearing the way - Fujifilm v AbbVie continues

While many of us were recovering from excessive helpings of turkey and Christmas pudding, a fascinating interim decision was handed down by Mr Justice Carr on 29 December in the biosimilars battle of Fujifilm Kyowa Kirin Biologics Co., Ltd and Others v AbbVie Biotechnology Limited[2016] EWHC 3383 (Ch). This concerns AbbVie's latest attempt to avoid a UK trial on its dosage regime patents covering its Humira product, in the form of an application for summary judgment, and strike out for abuse of process. A previous attempt by AbbVie to avoid a trial in the UK concerning the utility of 'Arrow' invalidity declarations was rejected by Carr J at first instance, as previously reported by the AmeriKat here. That earlier decision is currently under appeal (the appeal hearing took place on 28 and 29 November 2016, judgment has been reserved).

Biosimilars battle: keeping Carr J busy

What has changed to justify a further application?

AbbVie has now taken the following steps to try and avoid the UK trial scheduled for 16 January 2017:

1. AbbVie has de-designated the UK from one of the two patents that forms the subject of the trial (the '044 patent - see details of patents in issue below);

2. It has 'disapproved the text' of the other patent in issue - leading to its revocation (the '322 patent); and

3. AbbVie has offered an undertaking not to obtain patent protection in the UK that would be infringed by the Claimants' product as a result of their dosage regimens for the indications specified in the declarations sought.

In light of the above developments, the Court now had to consider whether there was a real prospect that the declarations of invalidity sought would serve a useful purpose. The answer from the Court is yes. This might seem counterintuitive in the abstract, but the Court's reasoning is firmly rooted in what it described as the "most unusual facts of this case".

Background

The dispute concerns the antibody adalimumab, marketed by AbbVie under the trade mark Humira. Humira is the highest selling prescription drug in the worl by global sales, with net sales in 2014 in excess of $12.5 billion. Humira is approved for the treatment of rheumatoid arthritis, psoriatic arthritis and psoriasis. The dosage regimes for those indications include the administration of 40mg of adalimumab every other week as a single dose via subcutaneous injection. AbbVie has obtained or applied for a number of patents and divisionals for adalimumab which claim the use of this dosage regime.

Sharp-eyed IP Kitten

Fujifilm Kyowa Kirin Biologics (FKB) and Samsung Bioepsis and Biogen Idec (SB) issued separate proceedings in 2015 and 2016 to revoke two of AbbVie's dosage regime patents (EP UK 2,940,044 and EP UK 1,944, 322) in an attempt to clear the way for their proposed biosimilar product launches after the SPC on Humira expires in Oct 2018. [The sharp-eyed IP Kitten notes that the earlier decision of the Court concerned another of AbbVie's patents - the '656 patent, rather than the '044 patent. This is because the '656 patent was 'disapproved' and withdrawn by AbbVie after proceedings had been issued in the UK. The '656 patent was replaced by the '044 divisional patent which was granted on 16 November 2016, and which claims the same subject matter as the '656 patent. The Claimants' pleadings were amended accordingly]. It is worth noting that AbbVie has now applied for a fifth divisional patent, the contents of which are not yet known to FKB and SB as it has not yet been published.

AbbVie's alleged strategy of delay and divisionals

FKB and SB alleged that AbbVie's actions set out at 1-3 above are consistent with its well-established strategy of dragging out proceedings for as long as possible, causing maximum expense and inconvenience to its opponents, and then throwing in the towel just before its patents are scrutinised by the court, whilst covering the same subject matter with further divisionals. The Claimants referred to AbbVie's previous activities at the EPO to support this contention, and also relied upon statements made by AbbVie's CEO where he expressed an intention to seek injunctive relief to prevent 'at-risk' launches of products which are biosimilar to Humira. Carr J. considered that there is at least a good arguable case that the trial judge will accept that AbbVie's actions are part of the strategy outlined above.

SJ: Would the declarations sought serve a useful purpose?

In its summary judgment application, AbbVie argued that there was no real prospect of the Court at trial exercising its discretion to grant the declarations sought in light of the changed factual circumstances. In essence, the Claimants have achieved the nullity and commercial purpose of the Arrow declarations sought in the proceedings in that they would have freedom to operate in the UK after October 2018. Further, AbbVie submitted that the English Court should not act as an advisory body for other Courts around Europe, which would be a disproportionate use of Court resources.

The Court disagreed for a number of reasons which included the following:

Although AbbVie has taken steps to avoid the UK trial, it has refused to submit to judgment or provide an acknowledgement in terms of the declarations of invalidity sought. This suggests that there is a useful purpose to the Claimants in obtaining the declarations;

The declarations would serve a useful purpose in protecting the Claimants' supply chains to the UK and Europe. There was evidence that certain components for SB's product are to be sourced in parts of Europe. In addition, AbbVie's threats of worldwide litigation are likely to have a chilling effect on competition from biosimilars, including on third party suppliers;

A useful purpose of the declarations is to provide clarity, including in the UK. In this respect, the undertakings offered by AbbVie are complex (and are currently in their fourth draft). Such clarity is necessary for the Claimants and third parties given AbbVie's conduct to date.

The court acknowledged that there would be 'spin-off value' in a declaratory judgment from the UK Court on other European jurisdictions, but observed that had this been the only 'useful purpose' relied upon, the continuation of litigation may not have been proportionate.

Strike out: abuse of process?

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Will the Arrow declarations hit the target?

Carr J concluded that it would not be a disproportionate use of resources for the UK court to allow the January trial to proceed, and that it would not be unfair to AbbVie. There is a real prospect that the court will consider that the grant of the declarations will serve a useful purpose. The Court also noted that this is a case "where a great deal is at stake.The size of the UK market is huge."

What next?﻿﻿

It would appear to be full steam ahead. The trial of the first Fujifilm and Samsung actions are due to comence on 16 January 2017. A second trial concerning another of Abbvie's dosage regime patents is scheduled for June 2017. The IPKat will keep you updated.

1 comment:

Leo
said...

This case could be seen as the UK Courts' view on the practice of filing multiple divisional applications as a precaution (in case earlier cases get revoked). It will be interesting to see to what extent the judgement on the invalidity declaration will be seen as applying to subsequent divisionals which are not yet granted, which I suppose will be a new res judicata principle.